Apogee Therapeutics Files 8-K Report

TL;DR

APOG filed an 8-K, mostly standard stuff, check exhibits for details.

AI Summary

On August 19, 2024, Apogee Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events beyond the filing itself were detailed in the provided text.

Why It Matters

This filing indicates that Apogee Therapeutics has submitted required documentation to the SEC, which may contain updates or disclosures relevant to investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report without immediate news of significant financial events or strategic shifts.

Key Players & Entities

• Apogee Therapeutics, Inc. (company) — Registrant
• August 19, 2024 (date) — Date of earliest event reported
• 001-41740 (other) — Commission File Number
• 93-4958665 (other) — I.R.S. Employer Identification No.
• 221 Crescent Street, Building 17, Suite 102b, Waltham, MA, 02453 (address) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.00001 — ch registered Common Stock, par value $0.00001 per share APGE The Nasdaq Global Ma

Filing Documents

• tm2421971d1_8k.htm (8-K) — 32KB
• tm2421971d1_ex99-1.htm (EX-99.1) — 15KB
• tm2421971d1_ex99-1img001.jpg (GRAPHIC) — 10KB
• 0001104659-24-090690.txt ( ) — 241KB
• apge-20240819.xsd (EX-101.SCH) — 3KB
• apge-20240819_lab.xml (EX-101.LAB) — 33KB
• apge-20240819_pre.xml (EX-101.PRE) — 22KB
• tm2421971d1_8k_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. On August 19, 2024, Apogee Therapeutics, Inc. (the "Company"or "Apogee") issued a press release announcing that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous half-life extended monoclonal antibody targeting OX40L, which is initially being developed as a treatment for people living with atopic dermatitis ("AD"). A copy of the press release is furnished herewith as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events On August 19, 2024, the Company announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous half-life extended monoclonal antibody targeting OX40L, which is initially being developed as a treatment for people living with atopic dermatitis. The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of APG990 and is expected to enroll approximately 40 healthy adults into five cohorts. Apogee expects interim data from the trial in 2025. Based on its preclinical studies, the Company believes APG990 can be dosed every three to six months in maintenance, which, if the Company's clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks. Cautionary Note Regarding Forward-Looking Statements Certain statements in this Current Report on Form 8-K may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future clinical trials, including its Phase 1 clinical trial for APG990; Apogee's plans for clinical trial design; the anticipated timing of the initiation of and results from Apogee's clinical trials, including data from Apogee's Phase 1 clinical trial of APG990; and the potential clinical benefit and half-life of APG990 and any other potential programs, including combination therapies. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are f

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits . The following exhibit is being furnished herewith: EXHIBIT INDEX Exhibit No. Description 99.1 Press Release, dated August 19, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Apogee Therapeutics, Inc. Date: August 19, 2024 By: /s/ Michael Henderson, M.D. Name: Michael Henderson, M.D. Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR